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| Name | Class |
|---|---|
| UK Radiopharma Alliance | UNKNOWN |
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This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiochemotherapy followed by brachytherapy | Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard | Radiation | Radiation then brachytherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker | deoxyribonucleotide levels | 3 months posttherapy |
| Biomarker | HPV DNA levels | 3 months posttherapy |
| Biomarker | Circulating tumor cell count | 3 months posttherapy |
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Inclusion Criteria:
- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.
Exclusion Criteria:
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This is an unblinded phase 0 window-of-opportunity intervention clinical trial to study biomarkers of uterine cervix cancer biology and disease progression in women undergoing cisplatin-based radiochemotherapy for advanced-stage uterine cervix cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Denise Fabian, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |